Medical Associate Director - Clinical Development

Cambridge

Medical Associate Director - Clinical Development

Position Summary:

This full time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office).

At Cycle Pharma, we’re recruiting for a Medical Associate Director - Clinical Development to join the team and provide medical leadership across our late-stage development programmes, shaping the clinical strategy and delivery of Phase 2 and Phase 3 studies in rare diseases.

Acting as the sponsor’s medical lead for assigned programmes, you’ll bring together rare disease expertise, clinical pharmacology, translational science and regulatory insight to design robust, patient-focused clinical development strategies — from early planning through to regulatory submission.

With a primary focus on rare metabolic diseases and opportunities to contribute across our wider neurology, immunology and oncology portfolio, you’ll tackle the scientific and clinical challenges of developing treatments for small, patient populations. You’ll play a key role in translating complex data and evolving regulatory requirements into meaningful clinical decisions and programmes designed to deliver clear, relevant evidence.

This is an opportunity for a physician with strong scientific depth, sound clinical judgement and a passion for drug development to take broad ownership, influence critical programme decisions and help shape clinical development within a growing organisation.

Our Company

At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision.



We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.

Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma

What you’ll be doing in this role:

- Lead the clinical development strategy for assigned programmes, translating target product profiles into integrated development plans and defining clinically meaningful, feasible study objectives, populations and endpoints for rare disease populations.
- Work closely with Regulatory Affairs on clinical and regulatory strategy, including endpoints,



natural history data and external control approaches; act as clinical lead in FDA meetings and author or review clinical content for regulatory submissions and briefing packages.
- Own the medical and scientific content of clinical protocols, amendments, statistical analysis plan inputs and informed consent materials, integrating nonclinical and translational evidence into dose selection and patient eligibility decisions.
- Lead scientific engagement with investigators, clinical experts, advisory boards and steering committees, and oversee clinical outcome assessment and patient-reported outcome strategies in collaboration with external experts and patient advocacy groups.
- Lead clinical pharmacology across assigned programmes, including dose and regimen selection, exposure-response analysis, dose justification for pivotal studies, and paediatric dose selection and extrapolation.
- Design and interpret clinical pharmacology studies, including bioavailability, bioequivalence, food effect, drug-drug interaction and special population studies; oversee population PK, PK/PD and physiologically based modelling, and define bridging strategies for reformulation programmes.
- Act as sponsor medical lead for assigned studies, overseeing CRO medical monitors, responding to medical queries and reviewing clinical data for eligibility, medically significant protocol deviations, and emerging safety and efficacy trends.
- Partner with Pharmacovigilance on serious adverse events, safety signal evaluation and reporting; support data monitoring committees.
- Contribute to publications and congress presentations, maintain awareness of evolving FDA, EMA and ICH guidance, and drive the development and implementation of clinical development procedures and standards.
- Contribute to departmental budgeting, resource planning and pr

📌 Medical Associate Director – Clinical Development (Town of Cambridge)
🏢 Cycle Pharmaceuticals
📍 Town of Cambridge